Quality control material for reagentless measurement of analytes

• US 7,172,902 B2
• Filed: 11/26/2003
• Issued: 02/06/2007
• Est. Priority Date: 06/12/1996
• Status: Expired due to Term

• Current Assignee: Nellcor Puritan Bennett LLC (Medtronic Plc)
• Original Assignee: Spectromedical Inc.
• Inventors: Samsoondar, James
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US10/721,253
• Publication Number:
  US 20040121476A1
• Time in Patent Office: 1,168 Days
• Field of Search: 436/8, 436/11, 436/12, 436/16, 436/66, 436/69, 436/80, 436/15, 702/19
• US Class Current: 436/8
• CPC Class Codes: G01N 2496/15 containing dyes to mimic optical absorption of, e.g. hemoglobin
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/103332 Bilirubin or uric acid standard or control
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control

Abstract

A method of monitoring calibration of a spectrophotometric apparatus that includes one or more than one calibration algorithm for one or more than one analyte, involves measuring absorbance of a quality control material with the apparatus to obtain a measurement, calculating one or more than one value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectrum having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and the spectral segment includes a principal calibration wavelength for the one or more than one analyte. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus having at least one primary calibration algorithm is also disclosed. Also provided is a method for selecting one or more than one substance as a quality control material for monitoring one or more than one primary calibration algorithm on a spectrophotometric apparatus. Also described is a quality control material for monitoring the calibration algorithms for two or more than two analytes including one or more than one substance having a combined absorption spectrum exhibiting a negative slope for a continuous spectral segment from about 5 nm to 200 nm in length, in a portion of an absorption spectrum.

Claims

1. A method of monitoring calibration of a spectrophotometric apparatus comprising one or more than one calibration algorithm for one or more than one analyte comprising:

i) measuring absorbance of a quality control material with said apparatus to obtain a measurement, said quality control material exhibiting an absorbance spectra characterized as having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length said spectral segment including a principal calibration wavelength for said one or more than one analyte;

ii) calculating one or more than one value from said measurement using said one or more than one calibration algorithm; and

iii) comparing said one or more than one value with an assigned value given to said quality control material for each of said one or more than one analyte, thereby monitoring said one or more than one calibration algorithm of said apparatus.

2. The method of claim 1, wherein said one or more than one analyte is one or more than one analyte in a biological fluid selected from the group consisting of serum, plasma, urine, synovial fluid and cerebrospinal fluid.

3. The method of claim 2, wherein said one or more than one analyte is bilirubin, and in said step of measuring (step i)) said spectral segment is selected from wavelengths of said absorbance spectra of from about 450 nm to about 600 nm.

4. The method of claim 2, wherein said one or more one analyte is an indicator of hemolysis, and in said step of measuring (step i)) said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 650 nm, said indicator of hemolysis selected from the group consisting of total hemoglobin (total Hb), oxy-hemoglobin (Oxy-Hb), and “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

).

5. The method of claim 2, wherein said one or more than one analyte is a hemoglobin-based blood substitute, and in said step of measuring (step i)) said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 700 nm.

6. The method of claim 2, wherein said one or more than one analyte is met-hemoglobin, and in said step of measuring (step i)) said spectral segment is selected from wavelengths of said absorbance spectra of from about 610 nm to about 690 nm.

7. The method of claim 2, wherein said one or more than one analyte is methylene blue, and in said step of measuring (step i)) said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 750 nm.

8. The method of claim 2, wherein said one or more than one analyte is biliverdin, and in said step of measuring (step i)) said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 800 nm.

9. The method of claim 1, wherein said quality control material comprises one or more than one susbstance, said one or more than one substance selected from the group consisting of a dye, copper sulfate total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), carboxy-hemoglobin (carboxy-Hb), “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

), cyanmet-hemoglobin (cyanmet-Hb), a hemoglobin-based blood substitute, a lipid emulsion, and a perfluorocarbon-like blood substitute.

10. The method of claim 9, wherein said absorbance spectra of said one or more than one substance is altered by adding a spectral modifier.

11. The method or claim 10, wherein said modifier causes a non-additive spectral shift in said absorbance spectra.

12. The method of claim 11, wherein said modifier is selected from the group consisting of a polymer, a protein, amaranth, and a combination thereof.

13. The method of claim 12, wherein said polymer is selected from the group consisting of polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG).

14. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus comprising at least one primary calibration algorithm comprising:

i) monitoring calibration of said apparatus as defined in claim 1;

ii) measuring absorbance values of said sample;

iii) calculating an order derivative of absorbance of said sample; and

iv) calculating a concentration of said one or more than one analyte in said sample, by applying said at least one primary calibration algorithm to said order derivative of absorbance value.

15. The method of claim 14, wherein said one or more than one analyte is one or more than one analyte in a biological fluid selected from the group consisting of whole blood, serum, plasma, urine, synovial fluid and cerebrospinal fluid.

16. The method of claim 15, wherein said one or more than one analyte is bilirubin, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 450 nm to about 600 nm.

17. The method of claim 15, wherein said one or more than one analyte is an indicator of hemolysis, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 650 nm, said indicator of hemolysis selected from the group consisting of total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), and “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

).

18. The method of claim 15, wherein said one or more than one analyte is a hemoglobin-based blood substitute, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 700 nm.

19. The method of claim 15, wherein said one or more than one analyte is met-hemoglobin, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 610 nm to about 690 nm.

20. The method of claim 15, wherein said one or more than one analyte is methylene blue, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 750 nm.

21. The method claim 15, wherein said one or more than one analyte is biliverdin, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 800 nm.

22. The method of claim 14, wherein said quality control material comprises one or more than one substance selected from the group consisting of a dye, copper sulfate, total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), carboxy-hemoglobin (carboxy-Hb), “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

), cyanmet-hemoglobin (cyanmet-Hb), a hemoglobin-based blood substitute, a lipid emulsion, and a perfluorocarbon-like blood substitute.

23. The method of claim 22, wherein said absorbance spectra of said one or more than one substance is altered by adding a spectral modifier.

24. The method of claim 23, wherein said modifier causes a non-additive spectral shift in said absorbance spectra.

25. The method of claim 24, wherein said modifier is selected from the group consisting of a polymer, a protein, and amaranth.

26. The method of claim 25, wherein said polymer is selected from the group consisting of polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG).

27. A method of monitoring calibration of a spectrophotometric apparatus comprising one or more than one calibration alaorithm for a perfluorocarbon-like blood substitute, turbidity, or a combination thereof, wherein said turbidity is measured in units of a lipid emulsion, comprising:

i) measuring absorbance of a quality control material with said apparatus to obtain a measurement, said quality control material exhibiting an absorbance spectra within the range from about 700 nm to about 1100 nm;

ii) calculating one or more than one value from said measurement using said one or more than one calibration algorithm; and

iii) comparing said one or more than one value with an assigned value given to said quality control material for each of said perfluorocarbon-like blood substitute, said turbidity, or a combination thereof;

thereby monitoring said one or more than one calibration alciorithm of said apparatus.

28. The method of claim 27, wherein said quality control material comprises one or more than one of a perflurocarbon-like blood substitute, and a lipid emulsion, and further comprises one or more than one substance, said one or more than one substance selected from the group consisting of a dye, copper sulfate, total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), carboxy-hemoglobin (carboxy-Hb), “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

), cyanmet-hemoglobin (cyanmet-Hb), and a hemoglobin-based blood substitute.

29. A reagentless method for determining the concentration of one or more than one of a perfluorocarbon-like blood substitute, turbidity, or a combination thereof in a sample in a spectrophotometric apparatus comprising at least one primary calibration algorithm comprising:

i) monitoring calibration of said apparatus as defined in claim 27;

ii) measuring absorbance values of said sample;

iii) calculating an order derivative of absorbance of said sample; and

iv) calculating a concentration of one or more than one of said perfluorocarbon-like blood substitute, said turbidity, or a combination thereof, wherein said turbidity is measured in concentration units of a lipid emulsion, by applying said primary calibration algorithm to said order derivative of absorbance value.

30. A method of monitoring calibration of a spectrophotometric apparatus comprising one or more than one calibration algorithm for a perfluorocarbon-like blood substitute, turbidity, or a combination thereof wherein said turbidity is measured in concentration units of a lipid emulsion, comprising:

i) measuring absorbance of a quality control material with said apparatus to obtain a measurement, said quality control material exhibiting an absorbance spectra characterized as having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm within the range of the absorbance spectra from about 700 nm to about 1100 nm;

ii) calculating one or more than one value from said measurement using said one or more than one calibration algorithm; and

iii) comparing said one or more than one value with an assigned value given to said quality control material for said one or more than one of a perfluorocarbon-like blood substitute, turbidity, or a combination thereof, wherein said turbidity is measured in units of a lipid emulsion;

thereby monitoring said one or more than one calibration algorithm of said apparatus.

31. The method of claim 30, wherein said quality control material comprises one or more than one of a perfluorocarbon-like blood substitute, and a lipid emulsion, and further comprises one or more than one substance, said one or more than one substance selected from the group consisting of a dye, copper sulfate, total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), carboxy-hemoglobin (carboxy-Hb), “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

), cyanmet-hemoglobin (cyanmet-Hb), and a hemoglobin-based blood substitute.

32. A reagentless method for determining the concentration of one or more than one of a perfluorocarbon-like blood substitute, turbidity, or a combination thereof in a sample in a spectrophotometric apparatus comprising at least one primary calibration algorithm comprising:

i) monitoring calibration of said apparatus as defined in claim 30;

ii) measuring absorbance values of said sample;

iii) calculating an order derivative of absorbance of said sample; and

iv) calculating a concentration of one or more than one of said perfluorocarbon-like blood substitute, said turbidity, or a combination thereof, wherein said turbidity is measured in concentration units of a lipid emulsion, by applying said primary calibration algorithm to said order derivative of absorbance value.

33. A method for selecting one or more than one substance as a quality control material for monitoring at least one primary calibration algorithm on a spectrophotometric apparatus comprising:

i) identifying a principal calibration wavelength for each of one or more than one substance;

ii) measuring absorbance spectra of said one or more than one substance; and

iii) selecting one or more than one of said one or more than one substance exhibiting a negative slope in said absorbance spectra, for a continuous spectral segment from about 5 nm to about 200 nm in length, said spectral segment including said principal calibration wavelength for each of said one or more than one substance.

34. The method of claim 33, wherein said one or more than one analyte is one or more than one analyte in a biological fluid selected from the group consisting of serum, plasma, urine, synovial fluid and cerebrospinal fluid.

35. The method of claim 34, wherein said one or more than one analyte is bilirubin, and in said step of selecting (step iii)), said spectral segment is selected from wavelengths of said absorbance spectra of from about 450 nm to about 600 nm.

36. The method of claim 34, wherein said one or more than one analyte is an indicator of hemolysis, and in said step of selecting (step iii), said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 650 nm, said indicator of hemolysis selected from the group consisting of total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), and “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

).

37. The method of claim 34, wherein said one or more than one analyte is a hemoglobin-based blood substitute, and in said step of selecting (step iii)), said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 700 nm.

38. The method of claim 34, wherein said one or more than one analyte is met-hemoglobin, and in said step of selecting (step iii)), said spectral segment is selected from wavelengths of said absorbance spectra of from about 610 nm to about 690 nm.

39. The method of claim 34, wherein said one or more than one analyte is methylene blue, and in said step of selecting (step iii)), said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 750 nm.

40. The method of claim 34, wherein said one or more than one analyte is biliverdin, and in said step of selecting (step iii)), said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 800 nm.

41. The method of claim 33, wherein said quality control material comprises one or more than one substance, said one or more than one substance selected from the group consisting of a dye copper sulfate, total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), carboxy-hemoglobin (carboxy-Hb), “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

), cyanmet-hemoglobin (cyanmet-Hb), a hemoglobin-based blood substitute, a lipid emulsion, and a perfluorocarbon-like blood substitute.

42. The method of claim 33 wherein in said step of identifying (step i)), said principal calibration wavelength of said analyte, and in said step of screening (step ii)) said absorption spectra of said one or more than one substance, are obtained on said spectrophotometric apparatus having one or more than one primary calibration algorithm.

43. A method for selecting one or more than one substance as a quality control material for monitoring at least one primary calibration algorithm on a spectrophotometric apparatus for one or more than one of a perfluorocarbon-like blood substitute and turbidity, wherein turbidity is measured in terms of concentration units of a lipid emulsion, comprising:

i) identifying a principal calibration wavelength for each of one or more than one of said perfluorocarbon-like blood substitute and said turbidity;

ii) measuring absorbance spectra of said one or more than one substance; and

iii) selecting one or more than one of said one or more than one substance exhibiting an absorbance value within the range from about 700 nm to about 1100 nm, wherein said range includes said principal calibration wavelength for one or more than one of said perfluorocarbon-like blood substitute and said turbidity.

44. A method for selecting one or more than one substance as a quality control material for monitoring at least one primary calibration algorithm on a spectrophotometric apparatus for one or more than one of a perfluorocarbon-like blood substitute and turbidity, wherein turbidity is measured in terms of concentration units of a lipid emulsion, comprising:

i) identifying a principal calibration wavelength for each of one or more than one of said perfluorocarbon-like blood substitute and said turbidity;

ii) measuring absorbance spectra of said one or more than one substance; and

iii) selecting one or more than one of said substances exhibiting absorbance spectra as having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm in length within the range of wavelengths from about 700 nm to about 1100 nm, wherein said range includes said principal calibration wavelength for one or more than one of said perfluorocarbon-like blood substitute and said turbidity.

45. A quality control material for monitoring the calibration algorithms for two or more than two analytes comprising, one or more than one substance having a combined absorption spectrum exhibiting a negative slope for one or more than one continuous spectral segment, wherein each of said one or more than one continuous spectral segment is from about 5 nm to 200 nm in length, and wherein said one or more than one continuous spectral segment includes one or more than one principal calibration wavelengths, for said two or more than two analytes.

46. The quality control material of claim 45, wherein one of said two or more than two analytes is bilirubin, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 450 nm to about 600 nm.

47. The quality control material of claim 45, wherein one of said two or more than two analytes is an indicator of hemolysis, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 650 nm, said indicator of hemolysis selected from the group consisting of total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), and “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

).

48. The quality control material of claim 45, wherein said two or more than two analytes are two or more than two analytes in a biological fluid selected from the group consisting of whole blood, serum, plasma, synovial fluid, cerebrospinal fluid, urine, mucus, lymphatic fluid, semen and feces.

49. The quality control material of claim 45, wherein one of said two or more than two analytes is a hemoglobin-based blood substitute, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 550 nm to about 700 nm.

50. The quality control material claim 45, wherein one of said two or more than two analytes is met-hemoglobin, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 610 nm to about 690 nm.

51. The quality control material claim 45, wherein one of said two or more than two analytes is methylene blue, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 750 nm.

52. The quality control material claim 45, wherein one of said two or more than two analytes is biliverdin, and said spectral segment is selected from wavelengths of said absorbance spectra of from about 650 nm to about 800 nm.

53. The quality control material claim 45, wherein one of said two or more than two analytes is either a simulator of turbidity or a perfluorocarbon-like blood substitute, said quality control material further characterized as having an absorbance spectrum within the range of from about 700 nm to about 1100 nm.

54. The quality control material of claim 53, wherein an absorbance spectrum of said one or more than one substance is altered by adding a spectral modifier.

55. The quality control material of claim 54, wherein said modifier causes a non-additive spectral shift in said absorbance spectra.

56. The quality control material of claim 55, wherein said modifier is selected from the group consisting of a polymer, a protein, and amaranth.

57. The quality control material of claim 56, wherein said polymer is selected from the group consisting of polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG).

58. The quality control material claim 45, wherein one of said two or more than two analytes is either a simulator of turbidity or a perfluorocarbon-like blood substitute, said absorption spectrum of said quality control material further characterized as having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm within the range of from about 700 nm to about 1100 nm.

59. The quality control material of claim 45, further comprising one or more than one substance selected from the group consisting of a dye copper sulfate, total hemoglobin (total-Hb), oxy-hemoglobin (Oxy-Hb), carboxy-hemoglobin (carboxy-Hb), “

total hemoglobin minus met-hemoglobin”

(“

total Hb minus met-Hb”

), cyanmet-hemoglobin (cyanmet-Hb), a hemoglobin-based blood substitute, a lipid emulsion, a perfluorocarbon-like blood substitute, and a combination thereof.

60. The quality control material of claim 59, wherein said one or more than one substance is not supplemented with bilirubin.